Comparison of the effect of brace adjustment with the optimal dosage method and the conventional method on clinical parameters
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 30 patients.
Settings and conduct
In this study, a comparison of brace adjustment based on the optimal applied force (new method) and patient's comfort (conventional method) on clinical parameters will be performed. Participants will be blinded. Moreover, the study will be performed in the biomechanics laboratory of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Patients with medial compartment of knee osteoarthritis with grade 2 and 3 according to the Kelgren Lawrence classification will be include . lateral compartment of knee osteoarthritis or grade 1 and 4 osteoarthritis will excluded.
Intervention groups
Both intervention and control groups will receive knee braces. The knee brace will be adjusted based on the optimal dose for the study group and based on patient comfort for the control group.
Comparison of the effect of brace adjustment with optimal dosage method and conventional method on clinical parameters
Public title
Determining the optimal pressure by the knee brace in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with medial knee osteoarthritis
Disease severity 2 and 3 based on Kelgren-Lawrence scale(Second degree: reduction of joint space, third degree: second degree symptoms with the appearance of osteophytes)
Age range 65-50 years
Body mass index less than 30
Exclusion criteria:
Heart and respiratory diseases that limit the ability of patients to walk or a history of stroke
lateral compartment knee osteoarthritis
Perform any surgery on any of the lower limb joints
Having a history of ligament reconstruction surgery, hip and knee arthroplasty and tibial osteotomy
Factors that lead to impaired orthosis use such as infection, neurological diseases, skin disorders
Quadriceps muscle weakness (strength lower or equal 3 based on manual muscle test)
Knee flexion contraction, ligament laxity
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple random method will be used. In this way, 30 cards numbered from 1 to 30 will be placed into a bowl. Then one card will be randomly taken out of the bowl each time. Thus, 15 cards will be selected and the number registered in them will be considered as study group.
The remaining numbers in the bowl will be considered as a control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study were not aware of the differences in knee joint pressure regulation between the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran,IRAN.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-08-08, 1400/05/17
Ethics committee reference number
IR.IUMS.REC.1400.414
Health conditions studied
1
Description of health condition studied
Medial knee compartment osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain level in patiants with medial knee osteoarthritis
Timepoint
Before the intervention and six weeks after the intervention
Method of measurement
Visual analoge scale
Secondary outcomes
1
Description
Function level in patiants with medial knee osteoarthritis.
Timepoint
Before and 6 weeks after intervention.
Method of measurement
The Western Ontario and McMaster Universities Arthritis Index questionnaire
2
Description
Satisfaction level in patiants with medial knee osteoarthritis.
Timepoint
Before and 6 weeks after intervention.
Method of measurement
Orthotics Prosthetics Users Survey.
Intervention groups
1
Description
Intervention group: Adjusted knee brace based on the optimal dose evaluated in the present study
Category
Rehabilitation
2
Description
Control group: Knee braces adjusted according to the conventional method (by the individual)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Sezar Ghobad's private clinic
Full name of responsible person
Mobina Khosravi
Street address
Shohada Square, Mojahedin Islam Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1686976613
Phone
+98 21 3354 2001
Email
ivco@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Iran University of Medical Science
Full name of responsible person
Dr SeyyedAbbas Motevalian
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
1686976613
Phone
+98 21 8670 1021
Fax
+98 21 8805 2248
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mobina khosravi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
No. 19, Moharrampour Alley., Tehranpars Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1686976613
Phone
+98 21 7670 0796
Email
mobinakhosravi80@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mobina khosravi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
No. 19, Moharrampour Alley., Tehranpars Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1686976613
Phone
+98 21 7670 0796
Email
mobinakhosravi80@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mobina khosravi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
No. 19, Moharrampour Alley., Tehranpars Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1686976613
Phone
+98 21 7670 0796
Email
mobinakhosravi80@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individuals information will remain confidential, but information about the variables studied in the present study can be shared.
When the data will become available and for how long
Up to two years after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to use the information for use in meta-analysis studies.
From where data/document is obtainable
Mobina khosravi
mobina khosravi80@yahoo.com
What processes are involved for a request to access data/document
Up to two years after the publication of the results, the applicant can send an email to the mentioned e-mail address and state the reason for the need for information. If the reason is reasonable, information will be sent to him as soon as possible.